23andMe bows to FDA, drops all medical information from new tests

Company had already pulled ads, and now it faces a class-action lawsuit.

After a partial attempt to get the Food and Drug Administration to ease up on its complaints, the personal genetics company 23andMe took a rather substantial step yesterday: it pulled all medically relevant information from its site, replacing its normal home page with a disclaimer. This move doesn't meet the FDA's original demand—that the company stop selling testing kits entirely—but it does suggest that 23andMe is now taking the issue seriously.

In late November, the FDA sent an open letter to 23andMe, noting that the company is offering a service that fits the legal definition of a medical device and is therefore subject to regulatory oversight. In fact, the company and agency had been negotiating for years regarding how best to bring the genetic tests into compliance. However, it seems that 23andMe stopped returning the agency's calls sometime earlier this year, and it then launched a new advertising campaign in which it promoted the medical relevance of its tests.

The FDA's letter seemed to alternate between disappointment and annoyance at these developments, but its proposed solution came down clearly on the annoyance end of the spectrum: it gave the company two weeks to stop offering its product. As a conciliatory gesture, 23andMe announced that it would stop promoting its products through advertising. Yesterday, it followed that up with a more dramatic step by removing all medical information from the Web portal that helps users interpret the results of the tests. Today, a visit to the company's website will bring up a dialog that asks the visitor to acknowledge the following:

I understand that 23andMe only sells ancestry reports and raw genetic data at this time. I understand 23andMe will not provide health-related reports. However, 23andMe may provide health-related results in the future, dependent upon FDA marketing authorization.

This is only a partial concession, however; users who purchased the kits before the FDA sent its letter will still be able to access any health-related results. Clearly, the company hopes to appease the FDA while still doing everything it can to both maintain its existing base of users and to keep selling additional kits. Whether the FDA will consider these concessions to be a sufficient compromise is difficult to guess.

While the company is trying to mend fences with the FDA, it's facing an assault in the legal arena. A class-action lawsuit was filed against 23andMe in a California federal court, claiming that everyone who purchased one of the test kits did so under fraudulent promises. Noting that 23andMe promised medical information but hadn't validated those claims to the FDA's satisfaction, the suit claims that the company's product "does none of those things, and the results it provides are not supported by any scientific evidence."

That's a somewhat extreme statement given that the information 23andMe provided was largely culled from the scientific literature. Nevertheless, it's clear that blood is now in the water, and the company will have to work very diligently to extract itself from the legal quagmire it now finds itself in.